Virus Therapy

Multiplo Test for HIV and Syphilis

Victoria, Canada

N/A

Waitlist Available

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

• Are at least 16 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new point-of-care test for HIV and Syphilis that can be used by non-registered healthcare providers in different settings. The goal is to show that untrained peer testers

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Who is the study for?

This trial is for individuals at least 16 years old who can read English or French, consent to the study, and provide a detailed medical history. Participants must be willing to give blood samples and undergo HIV and syphilis testing with the Multiplo TP/HIV Antibody Test. Those previously diagnosed with syphilis or with an unknown HIV/syphilis status (with last negative test over 3 months ago) may join.Check my eligibility

What is being tested?

The trial is evaluating whether non-professional health workers can accurately use a point-of-care test called Multiplo TP/HIV Antibody Test for detecting HIV and syphilis antibodies in fingerstick blood samples without increased risk of errors compared to trained healthcare professionals.See study design

What are the potential side effects?

Since this intervention involves only a diagnostic test using fingerstick blood samples, side effects are minimal but may include slight pain or bruising at the puncture site, bleeding, infection risk at the puncture site, and rare allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or older.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent positive and negative agreement of the Multiplo® TP/HIV Test performed by non-healthcare providers to the Participant's HIV and/or syphilis status confirmed by the lab results.

Secondary study objectives

Percent of correctly interpreted mock devices by untrained, non-healthcare professional operators

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: participants with known and unknown HIV and/or syphilis statusExperimental Treatment1 Intervention

All participants will undergo fingerstick blood testing with the test device administered by untrained non-professional health care providers, along with venous blood testing at a central laboratory using licensed gold standard comparator methods.

0 / 1Eligibility criteria met